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Real-Time Prediction of Polymer-Coated Multiparticulate Dissolution using Process Analytical Technology

Particle Characterization

Process Analytical Technology, or “PAT” is the term given to analytical instruments developed to measure certain attributes of product within the manufacturing process, eliminating, or substantially minimizing the need for sampling for off-line analysis. This approach offers process measurements in-situ with instant access to data, which facilitates rapid decisions during product development and manufacture. The results enable control decisions to be made based not just on a process recipe, but also on the true critical quality attributes (CQAs) of the material at that point in time. This allows for a more dynamic process, compensating for variabilities such as raw material variations or mechanical wear in processing components, and supports compliance with newer QA initiatives such as continuous verification. Additionally, the automated nature of PAT allows for data generation with minimal operator time.

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